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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM; DEVICE, THERMAL ABLATION, ENDOMETRIAL
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BOSTON SCIENTIFIC - FREMONT (CE) HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM; DEVICE, THERMAL ABLATION, ENDOMETRIAL Back to Search Results
Model Number M00658001R0
Device Problem Smoking (1585)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/26/2017
Event Type  malfunction  
Manufacturer Narrative
The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a genesys hydrothermablation endometrial ablation system was used in a hydrothermablation (hta) procedure performed on (b)(6) 2017.According to the complainant, during heating up phase of the procedure, the control unit started to smoke when the saline fluid leaked onto the machine while it powered up.The unit was immediately unplugged from the electrical.The procedure was not completed due to this event.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be fine.
 
Manufacturer Narrative
Analysis of the returned genesys hydrothermablation endometrial ablation system revealed that there were no alarms, smoke or cassette leaking were observed during the test.The unit passed the functional feature test.As the reported problem was not duplicated during the testing of the genesys console, the most probable root cause is not confirmed.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database revealed that no other complaints exist for the specified batch.
 
Event Description
It was reported to boston scientific corporation that a genesys hydrothermablation endometrial ablation system was used in a hydrothermablation (hta) procedure performed on (b)(6) 2017.According to the complainant, during heating up phase of the procedure, the control unit started to smoke when the saline fluid leaked onto the machine while it powered up.The unit was immediately unplugged from the electrical.The procedure was not completed due to this event.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be fine.
 
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Brand Name
HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
Type of Device
DEVICE, THERMAL ABLATION, ENDOMETRIAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - FREMONT (CE)
47215 lakeview blvd
north dock
fremont CA 94538
Manufacturer (Section G)
BOSTON SCIENTIFIC - FREMONT (CE)
47215 lakeview blvd
north dock
fremont CA 94538
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key6633332
MDR Text Key77542116
Report Number3005099803-2017-01830
Device Sequence Number1
Product Code MNB
UDI-Device Identifier08714729809357
UDI-Public(01)08714729809357(11)20111128
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00658001R0
Device Catalogue Number58001R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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